A prospective historically controlled study to assess the effect of an intervention integrating point-of-care hepatitis C (HCV) RNA testing, non-invasive liver fibrosis assessment, fast-tracked direct-acting antiviral (DAA) prescription, and linkage to hepatitis care (a 'one-stop-shop' intervention), on the proportion of participants initiating DAA therapy among people who are recently incarcerated within reception correctional centre(s) in Australia.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
541
Establishment of a 'one-stop-shop' hepatitis clinic, integrating point-of-care HCV RNA testing, followed by clinical assessment, non-invasive liver fibrosis assessment by fibro-elastography (Fibroscan), and early DAA prescription (for those with chronic HCV) followed by linkage to ongoing hepatitis care, all in the same 60-minute visit.
Mid North Coast Correctional Centre
Kempsey, New South Wales, Australia
The proportion of people who have initiated DAA therapy within 12 weeks from enrolment
Time frame: 12 weeks from enrolment
The proportion of people tested for HCV infection at 12 weeks from enrolment
Time frame: 12 weeks from enrolment
The proportion of participants who complete DAA therapy in prison
Time frame: End of Treatment (8 weeks from treatment initiation)
The proportion of people who have an end of treatment response
Time frame: End of Treatment (8 weeks from treatment initiation)
The proportion of people who have an HCV treatment response (sustained virological response)
Time frame: Sustained virological response at 12 weeks post treatment completion
The time taken from testing to each step in the care cascade
Time frame: Varying, up to 9 months post-enrolment.
The proportion of people lost to follow-up
Time frame: Varying, up to end of study (estimated to be 12 months from study commencement)
The acceptability of the 'one-stop-shop' (proportion of prisoners who refuse to participate)
Time frame: Varying, up to end of subject enrolment (estimated to be 12 months from study commencement)
The proportion of people reinfected at SVR12
Time frame: Varying, up to 9 months post-enrolment.
The proportion of people reporting injecting risk behaviours (at ETR and SVR12)
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Time frame: Varying, up to 9 months post-enrolment.
The cost-effectiveness of the 'one-stop-shop' (cost-ratio of 'one-stop-shop' and standard of care)
Time frame: End of study (estimated to be 12 months from study commencement)